The phase 2/3 clinical trials of Sputnik V will be conducted on 1,500 participants in Kanpur's Ganesh Shankar Vidyarthi Medical College.
The Sputnik V vaccine is likely to reach Kanpur’s Ganesh Shankar Vidyarthi Medical College by next week wherein the vaccine’s Phase 2 and Phase 3 human clinical trials will be conducted, India Today reported on Nov 15.
The Drug Control General of India had granted approval to Russian Direct Investment Fund (RDIF) and Dr Reddy's Laboratories Ltd to conduct late-stage clinical trials of the Russian COVID-19 vaccine, Sputnik V, in India, the sovereign wealth fund said on Nov. 14. The DGCI had earlier put a stop on Dr Reddy's Laboratories conducting clinical trials for Sputnik V. According to Reuters, the drug regulator had said the scale of Phase I and II trials conducted in Russia earlier this year was too small, requesting that they be repeated.
On Oct.13, the Hyderabad-based pharmaceutical firm had reapplied to the Indian drug regulator seeking permission to conduct combined phase 2 and 3 human clinical trials of the vaccine in the country, according to news agency PTI.
Now, following a new agreement, India will carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF was quoted by Reuters as saying. Under the deal, Dr. Reddy's will conduct the clinical trials and, subject to approval, distribute the finished vaccine in India. RDIF will supply 100 million doses to Dr. Reddy's.
Sputnik V, a vaccine against the novel coronavirus, has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and the RDIF.
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